Food and Drug Administration (FDA)
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It’s hard to say if it was actually a wild ride after the release of Alzheimer’s data, but Biogen shares dropped from $383.83 to $340.84 at the news, although it appears to be rebounding slightly.
The FDA notified Sarepta Therapeutics that its Phase I/IIa Micro-Dystrophin Gene Therapy Trial for Duchenne muscular dystrophy (DMD) has been placed on a clinical hold because of contamination of its therapeutic.
Shares of Nabriva Therapeutics are rising this morning after the company announced it acquired privately-held Zavante Therapeutics.
Boston-based resTORbio, which was spun out of Novartis in April 2017, announced positive topline results from its Phase IIb clinical trial of RTB101 in patients with respiratory tract infections (RTIs).
Chinese biopharmaceutical company, Changsheng Bio-Technology, is under investigation by Chinese regulators for allegedly falsifying data for a number of products.
If there’s one thing that defines the tenure of FDA Commissioner Scott Gottlieb, it is his outspoken mission to lower drug prices by introducing more competition into the biopharmaceutical market. And a big part of that mission has been doing what he can to boost the nascent biosimilar industry.
Arc Bio launched its proprietary antimicrobial resistance (AMR) software. It is the first in what it expects to be a series of next-generation sequencing (NGS)-based products for pathogen detection.
Merck presented results from Week 96 of its Phase III DRIVE-FORWARD clinical trial of doravirine in HIV. The data was presented in an abstract at the 22nd International AIDS Conference being held in Amsterdam.
Months after GlaxoSmithKline unveiled positive long-term data that showed Nucala is an effective treatment for patients with severe asthma, a U.S. FDA staff report is casting doubts on its potential as a treatment for chronic obstructive pulmonary disease (COPD).
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